3
Filtek Z250
™
Universal Restorative System
Technical Product Profile
1
2
Table of Contents
Background .................................................................................................................5
The Development Process...........................................................................................7
Chemistry .............................................................................................................7
Filler ...................................................................................................................10
Final Specifications............................................................................................ 11
Product Description...................................................................................................12
Indications for Use ....................................................................................................12
Technique Guides ......................................................................................................13
Customer Evaluations ...............................................................................................18
Global Simulated Operatory ..............................................................................18
Field Evaluation .................................................................................................19
Physical Properties ....................................................................................................20
Materials.............................................................................................................20
Volumetric Shrinkage.........................................................................................20
Post-Gel Shrinkage Strain..................................................................................21
Fracture Toughness ............................................................................................21
Flexural Modulus ...............................................................................................22
Flexural Strength................................................................................................22
Compressive and Diametral Tensile ..................................................................22
Wear ...................................................................................................................23
Particle Size Distribution ...................................................................................24
Technique Comparison..............................................................................................26
Questions and Answers .............................................................................................28
Instructions For Use ..................................................................................................29
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4
Background
The market for filling materials continues to proceed through an evolutionary process
that is fueled by a combination of factors including:
•
the desire for new materials by dentists
•
the inability of dental materials to provide consistent, esthetic restorations
every time
•
the efforts of dental manufacturers to optimize the properties most desired
by dentists
•
the dentist’s increased understanding of the choices made by manufacturers
to produce the materials
•
the changes in the industry, including reimbursement changes and patient
demands.
Composite materials have been used in dental practices to restore teeth since 3M first
introduced a composite to the dental market in 1964. The early materials were chemically
cured. These materials provided better esthetics than amalgam. However much had to be
learned about the physical properties that were required to survive in the oral environment. High wear, color changes, and lack of bonding to tooth surfaces were some of the
issues associated with these early materials.
Significant advances have been made since these early materials which have improved
upon many of the early materials’ weaknesses. Adhesive systems have been developed
that adhere well not only to enamel (with acid etching), but to moist dentin even when
placed in a humid environment. Composites have been made stronger, more wear resistant
and more color stable. Both types of materials were made curable on demand with high
intensity lights that emit light in the wavelength range of 400-500 nm.
In the 1980’s composites were developed that were specific to restoration type, i.e. materials were designed for anterior or posterior use. The main distinction between these materials was the high esthetic requirements for anterior use vs. the high strength requirement
for posterior use. One material was not available that offered both. The gap between the
two types of materials was very wide.
In the late 1980’s composite materials were developed to be used both for anterior and
posterior restorations. These materials narrowed the gaps between esthetics and strength.
Dentists were now able to use one composite material for all of their composite restorative
use. The reduction in inventory (one set of shades) and ease of material selection were
additional benefits realized that made the dental practice easier.
5
6
3M entered this “universal composite” marketplace in 1992 with 3M ™ Z100™ Restorative.
Z100 restorative provided dentists with a material that provided very good esthetics,
strength and wear resistance. Three clinical studies have documented the clinical success.
Two of the studies, conducted at Creighton University and University of Manitoba, examined the overall clinical performance over a 4-year period. The attributes examined include:
•
retention
•
color match
•
anatomic form
•
marginal adaptation
•
marginal discoloration
•
axial contour
•
proximal contact
•
secondary caries and
•
post-operative sensitivity
Both of these studies concluded that Z100 restorative is a viable and clinically acceptable
material for use in posterior restorations.
The third study, conducted at Catholic University at Leuven, closely examined the wear
of the material using a computerized measuring technique accurate to within 1 micron.
The 4-year clinical results of contact-free occlusal areas and occlusal contact areas demonstrated this material has wear similar to amalgam. Additionally, the wear rate of Z100
restorative on enamel in occlusal contact areas is comparable to the occlusal contact wear
for enamel on enamel. In an ideal situation, the wear of material from a composite restorative should match that of enamel.
Other studies by independent research organizations (who use a wide variety of practitioners) have confirmed the favorable results of the controlled clinical studies. Anterior
5-year clinical results were also reported on by one of these organizations. Again the
results indicated the high level of patient and doctor satisfaction with the performance
of Z100 restorative ( The Dental Advisor, August 1998, Volume 15, No. 6).
7
The Development Process
Three years ago, a survey was sent to 3M™ Z100 ™ Restorative users. The participants
were asked to rank 10 attributes for a material in the anterior and then in the posterior.
The results were not surprising and confirmed that restorative requirements differed between anterior and posterior use.
Figure 1.
Importance
Dual Cure
Durability
Esthetics
Fluoride Release
Handling
Low Modulus
Multiple Opacities
Polish
Shrinkage
Wear Resistance
Dual Cure
Durability
Esthetics
Fluoride Release
Handling
Low Modulus
Multiple Opacities
Polish
Shrinkage
Wear Resistance
0
1
2
3
4
5
6
7
8
1 is most important; 10 is least important
9
10
The most important features (of those asked) in anterior applications are esthetics and
durability. The next most important group included handling, shrinkage, wear resistance
and polish. For posterior applications, the groupings changed slightly. Durability and wear
resistance were in the most important group, followed by handling and shrinkage. The
other attributes could be grouped in one final category.
A product that is to be used in both anterior and posterior applications would have to
maximize the most important attributes for each category. Hence, attention was focused
on esthetics, durability, handling, shrinkage and wear resistance.
Dentists using Z100 restorative were asked what improvements could be made to
Z100 restorative to enhance the clinical performance. The top four responses were
reduce shrinkage, improve initial and sustained polish, improve marginal integrity and
reduce post-operative sensitivity.
Chemistry
Examination of the Z100 composition established the belief that modifying the resin
system could result in enhanced properties. The Z100 resin system consists of BIS-GMA
(Bisphenol A diglycidyl ether dimethacrylate) and TEGDMA (tri[ethylene glycol] dimethacrylate).
O
O
O
O
O
OH
bis-GMA
O
OH
8
The high concentration of a low molecular weight component, TEGDMA resulted in a
system that offered the following advantages:
•
The resultant high number of double bonds per unit of weight on a flexible backbone afforded the opportunity to have a high conversion of double bonds during
polymerization.
•
The low viscosity of the resin permits higher
filler loading than with BIS-GMA alone.
•
O
O
O
O
O
O
The high degree of crosslinking and compact molecule creates a very hard resin
matrix.
TEGDMA
However, the TEGDMA concentration also allows for some opportunities for improvements.
•
The relatively low molecular weight of TEGDMA contributes to the aging of an
uncured composite especially in capsules where there is a high ratio of surface
area to volume of paste. This material is labile enough to migrate into the capsule
walls leading to a thickening of the composite.
•
The low molecular weight and resultant high number of double bonds per unit of
weight creates a high degree of crosslinking creating a very rigid, stiff composite
with a relatively high amount of shrinkage.
•
TEGDMA is somewhat hydrophilic. The differences in moisture content of the
paste can contribute to thickening or softening of the paste in the capsule depending on the ambient moisture content of the surrounding air under extreme
climatic conditions.
The new resin system of 3M™ Filtek™ Z250 Universal Restorative consists of 3 major
components. In Filtek Z250 restorative, the majority of TEGDMA has been replaced with
a blend of UDMA (urethane dimethacrylate) and Bis-EMA(6)1 (Bisphenol A polyetheylene glycol diether dimethacrylate). Both of these resins are of higher molecular weight
and therefore have fewer double bonds per unit
of weight. The high molecular weight materials
O
O
O
O
also impact the measurable viscosity. A typical
N
O
O
N
H
H
O
O
batch of 3M™ Z100™ Restorative has a viscosUDMA
ity of 30,000 poise, whereas Filtek Z250 universal restorative has a target viscosity of 350,000
poise. Despite this large disparity, dentists may not distinguish any difference in handling
viscosity. However, the higher molecular weight of the resin results in less shrinkage,
reduced aging and a slightly softer resin matrix. Additionally these resins impart a greater
hydrophobicity and are less sensitive to changes in atmospheric moisture.
O
O
O
O
O
O
O
O
O
bis-EMA(6)
bis-EMA6
O
The final resin composition was determined on the basis of physical properties, including
compressive and diametral tensile strengths, shrinkage, wear resistance and customer
handling preferences. A Simulated Operatory (handling evaluation in heated typodonts)
was conducted to determine which resin system produced the most acceptable handling.
By combining the data from all tests, a resin composition which optimized the property
combination, was chosen.
1
Bis-EMA(6) contains, on average, 6 ethylene oxide groups per Bisphenol A grouping.
The reduction in shrinkage due to the new resin system was demonstrated using a mercury
dilatometer. The actual volumetric shrinkage is measured via this method. In this test, a
disc of uncured composite is placed on a glass stopper. This assembly is inserted into a
mercury-filled chamber and polymerized through a window with a curing light. The curing light intensity is also measured through the window to determine the intensity of light
reaching the sample. The volume change is recorded electronically over time. The final
volume is measured and then the per cent volumetric shrinkage is calculated.
Figure 2.
Volumetric Shrinkage
3
5 Minutes
30 Minutes
2
%
1
0
Filtek Z250
Z100
In this example, the samples were exposed for 40 seconds and the light intensity was
approximately 400mW/cm 2. 3M™ Filtek ™ Z250 Universal Restorative exhibited approximately an 18% reduction of total volumetric shrinkage when compared to 3M™ Z100™
Restorative at both 5 and 30 minutes.
The new resin system has demonstrated reduction in the aging process due to humidity
effects and resin sorption into the container walls. As composites age, their viscosity
increases. One method of monitoring the viscosity increase is to measure the resultant
increase in extrusion force. The chart below traces the extrusion force of the composite
system, over time. Note the virtually flat curve for the Filtek Z250 resin system.
Figure 3.
Aging
15
B
10
Extrusion Force, kg
25°C, 50%RH
B
B
B
B
B
5
0
Time
B
B
9
Filler
10
The filler in 3M ™ Filtek™ Z250 Restorative remains essentially the same as the 3M™
Z100™ Restorative filler. There have, however, been significant processing changes to
maximize filler consistency. The particle size distribution is 0.01µm to 3.5µm with an
average particle size of 0.6µm.
Using a Coulter ® LS Particle Size Analyzer, the filler distributions of Z100 Restorative
and Filtek Z250 universal restorative were measured. The data was reported based on the
number of particles and the volume the particles occupy at each particle diameter. Both
provide a different insight into the distribution. The number of particles per diameter
indicates the frequency a large particle may be encountered. One large particle can have
the same volume of numerous small particles. Both charts report cumulative data, that is,
the number or volume of particles at or below a specific diameter.
Figure 4.
Cumulative Particle
Size Distribution
Filtek Z250
Z100
Particle Diameter (µm)
Filtek Z250
Z100
Particle Diameter (µm)
The data shows that the particle size distribution for Filtek Z250 universal restorative
contains a larger number of finer particles than found in Z100 restorative. The photos
below were generated using scanning electron microscopy. Cured composite samples
were photographed at 2500× magnification. However, even at this magnification the very
small filler particles cannot be seen. Observation of the photos confirms the similarities
between the size and shapes of Filtek Z250 universal restorative and Z100 restoratives.
Figure 5.
SEMs 2500x
Filtek Z250 Restorative
Z100 Restorative
Final Specifications
A global Simulated Operatory was conducted to determine final handling specifications
for 3M™ Filtek™ Z250 Restorative. One hundred seventeen dentists participated in a blind
study that included six experimental pastes, 3M™ Z100™ Restorative, TPH ™ Spectrum and
Herculite XRV™. The dentists were currently using Z100 restorative, TPH or TPH Spectrum, Herculite XRV, Prodigy™, Tetric®, Tetric Ceram™ or Charisma ®. The participants
evaluated four of the nine pastes by placing them in an anterior and a posterior restoration
(in a mannequin heated to 37o C). Handling acceptance was determined by simply asking
the participants if they “liked or disliked” the handling after placing the material. After
handling all four materials, dentists were asked which paste they preferred as an anterior,
posterior and as a universal restorative material. In the chart below, the experimental
product formulations are indicated with the numbers 240, 241, 238, 239, 231 and 245.
Progressing from left to right on the chart (within the experimental materials) corresponds
to viscosity increases. Lots 238, 239, 231 and 245 show a very high acceptance.
Figure 6.
Handling Acceptance
100
Anterior
90
80
Posterior
70
BothUniversal
60
% Like 50
40
30
20
10
0
Z100
TPH
Herculite
XRV
240
241
238
239
231
245
When participants were asked to indicate which materials they prefer (selecting one out of
the four pastes handled), the following data was obtained.
40
Figure 7.
Handling Preference
Anterior
30
Posterior
% Preferred
Universal
20
10
0
Z100
TPH
Herculite XRV
Filtek Z250
Data for the experimental lots that meet the specification for Filtek Z250 universal restorative were combined and are presented as Filtek Z250 restorative. The handling preference for the new composite as a universal product versus TPH Spectrum, Herculite XRV
and Z100 restorative is particularly notable. The handling of Filtek Z250 restorative was
preferred more often for anterior restorations than Z100 restorative and Herculite XRV.
The handling of Filtek Z250 universal restorative was preferred more often for posterior
restorations than TPH Spectrum and Herculite XRV. The overall handling of Filtek Z250
universal restorative was preferred as an anterior and posterior restorative more often than
Z100 restorative, TPH Spectrum or Herculite XRV restoratives.
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12
Product Description
3M™ Filtek ™ Z250 Universal Restorative is an esthetic, light-cured, radiopaque composite
specifically designed for use in both anterior and posterior direct or indirect restorations.
Bonding to the tooth structure is accomplished by using a dental adhesive system, such as
3M™ Single Bond Dental Adhesive or 3M ™ Scotchbond™ Multi-Purpose Adhesive Systems.
40
Figure 8.
Adhesion
Dentin
Enamel
30
MPa
20
10
0
Scotchbond MultiPurpose
Single Bond
Filtek Z250 universal restorative is packaged in single-dose capsules and bulk syringes.
Filtek Z250 universal restorative is available in 15 shades that correspond to the most
commonly used shading system:
• A1, A2, A3, A3.5, A4
• B0.5, B1, B2, B3
• C2, C3, C4
• D3
• UD (universal dentin based on A3) and Incisal (more translucent)
The material is incrementally placed and cured in the cavity. The maximum cure depth
for an increment is 2.5mm for most shades. Each layer is cured for 20 seconds. The exceptions to this are the B0.5, C4 and UD shades that should be placed in increments of
less than 2.0mm. Each layer is then light cured for 30 seconds.
Indications for Use
Filtek Z250 universal restorative is indicated for use in the following types of restorations.
•
Direct anterior and posterior restorations
•
Sandwich technique with glass ionomer resin material
•
Cusp buildup
•
Core buildup
•
Splinting
•
Indirect anterior and posterior restorations including inlays, onlays and veneers
13
Technique Guides
Direct Posterior Restorations
3M™ Vitrebond™ Light Cure Glass Ionomer Liner/Base
3M™ Single Bond Dental Adhesive System
3M™ Filtek™ Z250 Universal Restorative
Prepare tooth and isolate.
Apply liner/base if desired:
• Mix a level scoop of Vitrebond powder and
a drop of Vitrebond liquid on a mixing pad.
• Apply a thin layer of the liner/base to dentin
surfaces using a ball applicator.
• Light cure for 30 seconds.
Etch:
• Apply 3M ™ Scotchbond ™ etchant to enamel
and dentin. Wait 15 seconds. Etchant on
Vitrebond base is not deleterious.
• Rinse.
• Blot excess water, leaving tooth moist.
Bond:
• Using a fully saturated brush tip for each coat,
apply 2 consecutive coats of 3M Single Bond
adhesive to enamel and dentin.
• Dry gently for 2-5 seconds.
• Light cure for 10 seconds.
Place Restorative:
• Place 3M Filtek Z250 restorative in increments
less than 2.5mm.
• Light cure each increment for 20 seconds
(Increments less than 2.0mm of B0.5, C4
and UD are cured 30 seconds).
Finish and Polish:
• Finish occlusal surface using an appropriate
finishing instrument.
• Finish interproximal surfaces with 3M™ SofLex ™ Pop-on ™ extra-thin discs and Sof-Lex
strips.
Check Occlusion:
• Check lateral and centric occlusion.
• Adjust if necessary.
Please refer to instructions for more detailed information
as well as precautionary and warranty information.
3M Customer Hotline 1-800-634-2249
© 1998 3M
14
Glass Ionomer/Composite Laminate/Sandwich
3M™ Single Bond Dental Adhesive System
3M™ Vitremer™ Core Buildup/Restorative
3M™ Filtek™ Z250 Universal Restorative
Indications
Direct posterior restorations where the benefits of glass ionomers and composites are desired.
Prepare/Prime:
• Note that this technique is indicated where cavity design
allows for a minimum composite restorative thickness of
2mm on the occlusal surface.
• Conservatively prepare the tooth; place matrix bands and
wedges.
• Apply Vitremer primer for 30 seconds to all dentin surfaces;
air dry.
• Light cure for 20 seconds.
Apply Glass Ionomer:
• Mix Vitremer powder and liquid according to product
instructions; back load into delivery tip.
• Syringe Vitremer restorative into the preparation, extending
no further than just apical to the proximal contact point.
• Light cure for 40 seconds.
Freshen Preparation Margins/Etch:
• Using a rotary instrument, remove excess Vitremer restorative
material from enamel margins and cavity walls that will be
bonded.
• Apply 3M ™ Scotchbond ™ etchant to enamel and exposed
dentin; wait 15 seconds, then rinse. Blot excess water, leaving
tooth moist.
Bond:
• Using a fully saturated brush tip for each coat, apply 2
consecutive coats of Single Bond adhesive to enamel,
dentin and Vitremer restorative base increment.
• Dry gently for 2-5 seconds.
• Light cure for 10 seconds.
Place Restorative:
• Place 3M Filtek Z250 restorative in increments less
than 2.5mm.
• Light cure each increment for 20 seconds (Increments
less than 2.0mm of B0.5, C4 and UD are cured 30 seconds.)
Finish and Polish:
• Finish occlusal surface using an appropriate finishing
instrument.
• Finish interproximal surfaces with 3M™ Sof-Lex ™ Pop-on ™
extra-thin discs and Sof-Lex strips.
Check Occlusion:
• Check lateral and centric occlusion.
• Adjust if necessary.
Please refer to instructions for more detailed information
as well as precautionary and warranty information.
3M Customer Hotline 1-800-634-2249
© 1998 3M
Compomer/Composite Laminate/Sandwich
3M™ Single Bond Dental Adhesive System
3M™ F2000 Compomer Restorative
3M™ Filtek™ Z250 Universal Restorative
Indications
Direct posterior restorations where the benefits of a compomer and composite are desired.
Prepare and Isolate Tooth.
Etch:
• Apply 3M ™ Scotchbond ™ etchant to enamel and dentin;
wait 15 seconds.
• Rinse.
• Blot excess water, leaving tooth moist.
Bond:
• Using a fully saturated brush tip for each coat, apply 2
consecutive coats of Single Bond adhesive to enamel
and dentin.
• Dry gently for 2-5 seconds.
• Light cure for 10 seconds.
Place Compomer:
• Place F2000 compomer in increments.
• Place F2000 compomer no further than just apical to
the proximal contact point.
• Remove any excess compomer inadvertently placed on
enamel margins before light curing.
• Light cure each compomer increment for 40 seconds.
Place Composite:
• Place 3M Filtek Z250 in increments less than 2.5mm.
• Light cure each increment for 20 seconds (Increments less
than 2.0mm of B0.5, C4 and UD are cured for 30 seconds).
Finish and Polish:
• Finish occlusal surface using an appropriate finishing
instrument.
• Finish interproximal surfaces with 3M™ Sof-Lex ™ Pop-on ™
extra-thin discs and Sof-Lex strips.
Check Occlusion:
• Check lateral and centric occlusion.
• Adjust if necessary.
Please refer to instructions for more detailed information
as well as precautionary and warranty information.
3M Customer Hotline 1-800-634-2249
© 1998 3M
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16
Direct Composite Restorative Class III & V Restorations
3M™ Single Bond Dental Adhesive System
3M™ Filtek™ Z250 Universal Restorative
Indications
- Class V cavities and cervical erosion/abrasion lesions and root caries lesion
- Class III cavities
Prepare the Tooth:
• Select shade using the shade guide.
• Isolate the tooth.
• Remove caries.
Etch:
• Apply 3M ™ Scotchbond ™ etchant to enamel and dentin;
wait 15 seconds.
• Rinse.
• Blot excess water, leaving tooth moist.
Bond:
• Using a fully saturated brush tip for each coat, apply 2
consecutive coats of Single Bond adhesive to enamel and
dentin.
• Dry gently for 2-5 seconds.
• Light cure for 10 seconds.
Place Composite:
• Place Filtek Z250 restorative in layers less than 2.5mm.
• Cure each increment for 20 seconds (Increments less than
2.0mm of B0.5, C4 and UD are cured for 30 seconds).
• For maximum esthetics and surface smoothness a veneer of
3M™ Silux Plus ™ Restorative may be placed and cured over
Filtek Z250 restorative.
Finish/Polish:
• Use the 3M ™ Sof-Lex ™ Finishing and Polishing System
(discs and strips) for finishing and polishing the restoration.
Please refer to instructions for more detailed information
as well as precautionary and warranty information.
3M Customer Hotline 1-800-634-2249
© 1998 3M
Class IV Restoration
3M™ Single Bond Dental Adhesive System
3M™ Filtek™ Z250 Universal Restorative
Preparation:
- Select shade.
- Prepare the tooth.
- Bevel enamel margins.
Etch:
• Apply 3M ™ Scotchbond ™ etchant to enamel and dentin;
wait 15 seconds.
• Rinse.
• Blot excess water, leaving tooth moist.
Bond:
• Using a fully saturated brush tip for each coat, apply
2 consecutive coats of Single Bond adhesive to enamel
and dentin.
• Dry gently for 2-5 seconds.
• Light cure for 10 seconds.
Place Composite:
• Place Filtek Z250 restorative in layers less than 2.5mm.
• Cure each increment for 20 seconds (Increments less than
2.0mm of B0.5, C4 and UD are cured 30 seconds).
• For maximum esthetics and surface smoothness a veneer
of 3M ™ Silux Plus ™ restorative may be placed and cured
over Filtek Z250 restorative.
Finish and Polish:
• Use the 3M ™ Sof-Lex ™ Finishing and Polishing System
(discs and strips) for finishing and polishing the restoration.
Please refer to instructions for more detailed information
as well as precautionary and warranty information.
3M Customer Hotline 1-800-634-2249
© 1998 3M
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18
Customer Evaluations
Global Simulated Operatory
Dentists participating in the Global Simulated Operatory (see Final Specification section)
were asked to rate five handling attributes for anterior restorations on a scale of 1 to 7 for
each paste. The “ideal” rating for viscosity, stickiness to instrument, flow and resistance
to slump was 4. The “ideal” rating for ease of shaping was 7. The results for anterior
handling are displayed below. In most cases 3M ™ Filtek ™ Z250 Universal Restorative and
3M™ Z100™ Restorative are very close to the ideal.
Figure 9.
Anterior Handling
7
7 is Ideal
Filtek™
Z250
6
4 is Ideal
Z100™
5
4
TPH™
3
Herculite
XRV™
2
1
0
Viscosity
Stickiness
Flow
Slump Ease of Shaping
Resistance
Dentists participating in the Global Sim Op were asked to rate seven handling attributes
for posterior restorations on a scale of 1 to 7 for each paste. The “ideal” rating for viscosity, stickiness to instrument, flow and resistance to slump was 4. The “ideal” rating for
cavity/marginal adaptation, ease of shaping and packability was 7. The results for handling in a posterior restoration are displayed below. As in the anterior handling evaluation, the average values for Filtek Z250 universal restorative and Z100 restorative are
closest to the ideal rating than for the other composites included in the study.
Figure 10.
Posterior Handling
7
7 is Ideal
Filtek™
Z250
6
4 is Ideal
Z100™
5
TPH™
4
Herculite
XRV™
3
2
1
0
Viscosity
Stickiness
Flow
Slump
Resistance
Adaptation
Ease of Shaping
Packable
Field Evaluation
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19
20
Physical Properties
Materials
Designation
Product
Charisma
XRV
Charisma
Manufacturer
®
Heraeus Kulzer
™
Herculite XRV
Kerr
™
Prodigy
Prodigy
TPH
TPH™ Spectrum
Caulk ®/Dentsply ®
Kerr
Tetric Ceram
Tetric Ceram™
Vivadent
™
Z100
Z100 Restorative
3M™
Z250
Filtek ™ Z250
Universal Restorative
3M™
Shrinkage
Shrinkage of composite is measured in a variety of methods. Some methods measure the
total amount of shrinkage volumetrically or linearly. Another method measures a portion
of the shrinkage that occurs after the composite has lost the ability to flow (post-gel).
Volumetric Shrinkage
Another method for determining polymerization shrinkage was described by Watts and
Cash (Meas. Sci. Technol. 2(1991) 788-794). In this method, a disc shaped test specimen
is sandwiched between two glass plates and light cured through the lower rigid plate. The
flexible upper plate is deflected during the
polymerization of the test specimen. The less
the flexible plate bends, the lower the shrinkTransducer
Deflection
age. Deflection is measured and recorded as
a function of time. Although this process
Flexible Slide
actually measures linear shrinkage, volumetRigid Slide
ric shrinkage was closely approximated due
to the fact that the dimensional changes were
Light Source
limited to the thickness dimension. The
lower the value, the less the shrinkage.
In this test, samples were exposed for 60 seconds to a 3M™ Visilux™ 2 Visible Light Curing Unit. The final shrinkage was recorded 4 minutes after the end of light exposure. As
the chart below shows, the value for Filtek Z250 universal restorative is statistically lower
than the other materials tested. Charisma, Herculite XRV, TPH Spectrum, Tetric Ceram
and Z100 restorative exhibited statistically similar results.
4
Figure 11.
Shrinkage
3
%
2
1
0
Filtek Z250
Z100
Charisma
Herulite
XRV
Prodigy
TPH
Tetric
Ceram
Post-Gel Shrinkage Strain
Post-gel shrinkage is reported to be the shrinkage that occurs after the material has gelled,
i.e., the material has lost its ability to flow. Shrinkage stresses that occur in the pre-gel
phase can be relieved readily by the flow of the material. However, stresses occurring
during the post-gel phase cannot be relieved by material
flow. These stresses remain built-up in the material and may
cause fatigue within the material or at the composite-bond
Light
Sample
interface over time. Strain gauges have been shown to be
Strain Gauge
an effective method for indicating linear post-gel polymerSupport
ization shrinkage stress in composites.
In this method a sample of composite is placed on top of a strain gauge. The composite
samples were then light-cured for 60 seconds. The final shrinkage strain (in µStrain),
which is the result of dimensional changes in the composite that occurred during polymerization, was recorded 4 minutes after the light was turned off.
The chart below depicts these final values. 3M ™ Filtek ™ Z250 Universal Restorative displayed significantly less shrinkage strain than Charisma ®, Prodigy ™, TPH Spectrum ™,
Tetric Ceram™ and 3M ™ Z100™ Restorative.
2500
Figure 12.
Post-Gel
Shrinkage Strain
2000
1500
µStrain
1000
500
0
Filtek Z250
Z100
Charisma
Herculite
XRV
Prodigy
TPH
Tetric
Ceram
Fracture Toughness
The values reported for fracture toughness (KIC) are related
to the energy required to propagate a crack. In this test a
short rod of material is cured. A chevron or notch is cut into
the cylinder and the parts on either side of the chevron are
pulled apart.
Below are the 24-hour values for wet fracture toughness. The wet fracture toughness for
Filtek Z250 universal restorative was determined to be significantly different than Charisma, Prodigy, Tetric Ceram and Z100 restorative.
1.75
Fracture 13.
Fracture Toughness
1.5
1.25
MN/m
1.5
1
0.75
0.5
0.25
0
Filtek Z250
Z100
Charisma
Herculite
XRV
Prodigy
TPH
Tetric
Ceram
21
Flexural Modulus
22
Flexural modulus is a method of defining a material’s stiffness. A low modulus indicates a flexible material. The flexural
modulus is measured by applying a load to a material specimen that is supported at each end.
The flexural modulus for 3M™ Filtek ™ Z250 Universal Restorative is intermediate
and comparable to Herculite XRV ™ and TPH Spectrum ™. Comparatively high flexural
modulus materials include 3M™ Z100 ™ Restorative. Prodigy ™ Charisma ® and Tetric
Ceram ™ have a lower modulus than Filtek Z250 universal restorative.
15,000
Figure 14.
Flexural Modulus
12,000
9,000
MPa
6,000
3,000
0
Filtek Z250
Z100
Charisma
Herculite
XRV
Prodigy
TPH
Tetric
Ceram
Flexural Strength
Flexural strength is determined in the same test as flexural
modulus. Flexural strength is the value obtained when the
sample breaks. This test combines the forces found in compression and tension. As shown in the graph below the flexural strength of Filtek Z250 restorative is statistically higher
than Charisma but similar to all other materials tested.
200
Figure 15.
Flexural Strength
150
MPa
100
50
0
Filtek Z250
Z100
Charisma
Herculite
XRV
Prodigy
TPH
Tetric
Ceram
Compressive and Diametral Tensile
Compressive strength is particularly important because of chewing forces. Rods are made
of the material and simultaneous forces are applied to the opposite ends of the sample
length. The sample failure is a result of shear and tensile forces.
The compressive strengths of various materials are shown below.
Filtek Z250 universal restorative was not statistically different from
Charisma, Prodigy and TPH Spectrum. However it was significantly
higher than Herculite XRV and Tetric Ceram.
Figure 16.
Compressive Strength
500
23
400
300
MPa
200
100
0
Filtek Z250
Z100
Charisma
Herculite
XRV
Prodigy
TPH
Tetric
Ceram
Diametral Tensile strength is measured using a similar apparatus. Compressive forces are
applied to the sides of the sample, not the ends, until fracture occurs.
The diametral tensile strength of 3M ™ Filtek ™ Z250 Universal Restorative was significantly higher than Charisma® and Tetric Ceram™. Filtek
Z250 restorative showed similar results to Prodigy™. These data are
reported in the chart below.
120
Figure 17.
Diametral
Tensile Strength
100
80
MPa 60
40
20
0
Filtek Z250
Z100
Charisma
Herculite
XRV
Prodigy
TPH
Tetric
Ceram
Wear
The wear rate was determined by an in-vitro 3-body wear test. In this test, composite
(1st body) is loaded onto a wheel (shaded slots in the diagram) which contacts another
wheel which acts as an “antagonistic cusp” (2nd body). The two wheels counter-rotate
against one another dragging an abrasive slurry (3rd body) between them. Dimensional loss during 156,000 cycles is determined by profilometry at regular intervals (i.e., after every 39,000
cycles). As the wear in this method typically follows a linear
pattern, the data is plotted using linear regression. The wear rates,
i.e., the slope of the lines, are determined. The comparison of
rates reduces some of the variability in the test due to sample
preparation and can be predictive of anticipated wear beyond the length of the actual test.
The wear rate data shown below indicates the wear rate of Filtek Z250 universal restorative is intermediate between Z100 restorative and other materials tested.
Figure 18.
Wear
6
5
4
µ Loss/39,000 Cycles 3
2
1
0
Filtek Z250
Z100
Charisma Herculite
XRV
Prodigy
TPH
Tetric
Ceram
Particle Size Distribution
24
Cross-Section SEM
In this column are SEMs (scanning electron
micrographs) of cured universal composites
in cross section. Observations of the particle
size distributions and shapes can be made by
comparing these photos. All samples are
magnified at 2500×. However, even at this
magnification, the very small filler particles
are not visible.
Surface SEM After Wear Wheel Abrasion
In this column are SEMs (2500× magnification)
of the surface of a composite sample after
156,000 cycles of a 3-body wear test. See Wear
Wheel Section, if desired, for more detailed description of the test methodology. Samples were
not obtained from the same wheel. These photos may be indicative of the polish retention of
restored occlusal surfaces.
The Filtek 3M™ Z250™ Restorative filler consists of
the same proprietary synthetic, rounded zirconia/silica
particles as 3M™ Z100™ Restorative. The particle size
distribution of Z250 restorative is 0.01 to 3.5 µm. The
average particle size is 0.6µm.
The surface of the Filtek Z250 sample is irregular but
not ditched or pitted from filler particle loss.
The synthetic proprietary Z100 restorative filler is
composed of rounded zirconia/silica particles. The
particle size distribution of Z100 restorative is 0.01 to
3.3µm. The white splotches are artifacts of the sample
preparation.
The SEM of the sample surface after wear wheel
abrasion of Z100 restorative confirms the similarities
in the filler distribution between Z100 restorative and
Filtek Z250.
The Charisma® restorative filler consists of jagged
barium glass and silica particles (average particle size
of 0.4µm). The average particle size is reported to be
0.7µm. It appears that the distribution of particles is more
narrow than for Filtek Z250 or Z100 restoratives.
The surface of Charisma after wear abrasion is rough.
However there is no evidence of pitting due to large
particle loss.
Filtek Z250
Restorative
Z100 Restorative
Charisma Restorative
Tetric Ceram
25
The filler for Tetric Ceram™ is a combination of barium
glass, ytterbium trifluoride, barium aluminum
fluorosilicate glass, silica, and spheroid mixed oxides. The
jagged filler particles in the SEM vary in appearance,
shape and sizes. Although the composition of the large
blotches is unclear, they are not an artifact of the sample
preparation. The product instructions state the average
particle size is 0.7µm with range from 0.04-3.0µm.
The SEM of the surface of Tetric Ceram after wear
abrasion shows evidence of the largest particles. The
surface is very rough. There is some evidence of pits
(loss of filler particles) and some areas appear as if
flaking occurred.
The filler particles in Prodigy™ are irregular and
jagged. This is indicative of a ground glass filler. The
average particle size is claimed to be 0.6µm.
The surface of Prodigy after wear wheel abrasion
appears rough. Although it does appear somewhat
smoother than the Z100 restorative sample.
The filler particles in Herculite XRV™ appear very
similar to Prodigy in both shape and size. The average
particle size is claimed to be 0.6µm also.
It is apparent in this SEM of Herculite XRV that the
resin system can contribute to the surface smoothness
after abrasive wear. The surface of Herculite XRV is
very rough and irregular.
The filler in TPH™ and TPH Spectrum™ contains
some relatively large particles. The jagged and
irregular shapes indicate the filler is simply ground
glass. Many of the particles are 5µm.
The SEM of TPH Spectrum after abrasive wear
demonstrates one of the effects of the large particles in
a composite. The rough surface exhibits pits and craters
which could be caused by loss of large particles.
Prodigy
Herculite XRV
TPH Spectrum
26
Technique Comparison
A comparison of the time to cure an increment for each material is provided below.
Material
3M™ Filtek™ Z250
Restorative
3M™ Z100™
Restorative
Charisma®
Herculite XRV™
Prodigy™
TPH Spectrum™
Tetric Ceram™
Increment Depth
Cure Time
Shades
(mm)
(sec)
A1, A2, A3, A3.5, A4
B1, B2, B3, C2, C3
D3, I
2.5
20
B0.5, C4, UD
2.0
30
A1, A2, A3, A3.5 B2, B3,
C2, C4, D3, P, I
2.5
40
A4, CY, CG, UD
2.0
40
A10, A20, A30, A35,
B20, B30, C20, BO, YO, I
2.0 1
20
All Shades
2.0
3.0
20
30
A1, A2, A3, B1, B2,
C2, D2, D3, I, UO
2.0
40
A2, A3, A3.5, B2, B3, C2
3.0
4.0
B1
3.5
5.5
20
40
C4
2.5
3.5
20
40
A1, A2, A3, A3.5, A4,
B2, B3, C3, D3, T
105, 540
2.0
40
B2 Opaque, A3.5 Opaque,
A4 Opaque
1.5
40
2
20
40
1
The product instructions state “It is general not recommended to cure Charisma beyond 2 mm layer thickness
despite the fact that the syringe labels allow by far more curing depth.”
2
Product instructions also provide cure times when curing through 1mm of enamel. Additionally, the instructions state to place the composite in increments 2mm or less in posterior Class I and II restoration.
The time to cure a 5mm depth (in numerous increments) can vary from 40 seconds
(2 increments of many of the materials) to 160 seconds (Tetric Ceram, opaque or
dentin shades, 4 increments).
Shades
Number of
Increments to
Cure 5mm of
Composite
3M™ Filtek™
A1, A2, A3, A3.5, A4
2
40
Z250 Restorative
B1, B2, B3, C2, C3
B0.5, C4, UD
3
90
A1, A2, A3, A3.5
2
80
A4, CY, CG, UD
3
120
A10, A20, A30, A35,
3
60
All shades
2
60
A1, A2, A3, B1, B2,
3
120
31
60
3
120
4
160
Material
Approximate
Time to
Cure 5mm of
Composite
D3, I
3M™ Z100™
Restorative
Charisma®
B2, B3, C2, C4, D3, P, I
B20, B30, C20, BO, YO, I
Herculite XRV™
Prodigy™
C2, D2, D3, I, UO
TPH Spectrum™
A2, A3, A3.5,B2, B3, C2
B1, C4
Tetric Ceram™
A1, A2, A3, A3.5, A4,
B2, B3, C3, D3, T
105, 540
B2 Opaque, A3.5 Opaque,
A4 Opaque
1
As more posterior than anterior restorations could be 5mm deep, the instructions for posterior restorations
were used.
27
28
Questions and Answers
Does the shorter cure time for 3M™ Filtek™ Z250 Restorative affect the operatory
light stability?
No. As with any composite, care must be taken to minimize exposure to operatory light
during placement.
How is it that 2.5mm increments (for most shades) of Filtek Z250 restorative can
be cured in 20 seconds instead of 40 seconds like with 3M
™ Z100™ Restorative?
The new resin system with the higher molecular weight materials yield fewer double
bonds to crosslink so the resin cures more efficiently. In addition, the cure depths and
times for Z100 restorative were conservative.
Instructions For Use
3M™ Filtek™ Z250 Restorative
General
3M™ Filtek™ Z250 restorative material is a visible-light activated, radiopaque, restorative composite. It is designed for use in both anterior and posterior restorations. The filler
in Filtek Z250 restorative is zirconia/silica. The inorganic filler loading is 60% by volume
(without silane treatment) with a particle size range of 0.01 to 3.5 microns. Filtek Z250
restorative contains BIS-GMA, UDMA and BIS-EMA resins. A 3M dental adhesive is
used to permanently bond the restoration to the tooth structure. The restorative is available
in a variety of shades. It is packaged in traditional syringes and single-dose capsules.
Indications
Filtek Z250 restorative is indicated for use in:
Direct anterior and posterior restorations
Core Build-ups
Splinting
Indirect restorations including inlays, onlays and veneers
Precautions
Filtek Z250 restorative contains methacrylates A small percentage of the population is
known to have an allergic response to acrylate resins. To reduce the risk of allergic response, minimize exposure to these materials. In particular, exposure to uncured resin
should be avoided. Use of protective gloves and a no-touch technique is recommended. If restorative material contacts skin, wash immediately with soap and water.
Acrylates may penetrate commonly used gloves. If restorative contacts glove, remove
and discard glove, wash hands immediately with soap and water and then reglove. If
accidental contact with eyes or prolonged contact with oral soft tissues occurs, flush immediately with large amounts of water.
Instructions for Use
I. Preliminary
A. Prophy: Teeth should be cleaned with pumice and water to remove surface
stains.
B. Shade Selection: Before isolating the tooth, select the appropriate shade(s) of
restorative material. Shade selection accuracy can be enhanced by the following
hints.
1.
Shade: Teeth are not monochromatic. The tooth can be divided into three
regions, each with a characteristic color.
a)
Gingival area: Restorations in the gingival area of the tooth will have
various amounts of yellow.
b) Body area: Restorations in the body of the tooth may consist of shades
of gray, yellow or brown.
c)
2.
Incisal area: The incisal edges may contain a blue or gray color. Additionally, the translucency of this area and the extent of the translucent
portion of the tooth to be restored and neighboring teeth should be
matched.
Restoration depth: The amount of color a restorative material exhibits is
effected by its thickness. Shade matches should be taken from the portion of
29
the shade guide most similar to the thickness of the restoration.
30
3.
Mock-up: Place the chosen shade of the restorative material on the unetched
tooth. Manipulate the material to approximate the thickness and site of the
restoration. Cure. Evaluate the shade match under different lighting sources.
Remove the restorative material from the unetched tooth with an explorer.
Repeat process until an acceptable shade match is achieved.
C. Isolation: A rubber dam is the preferred method of isolation. Cotton rolls plus
an evacuator can also be used.
II. Direct Restorations
A. Cavity Preparation:
1.
Anterior restorations: Use conventional cavity preparations for all Class III,
IV and Class V restorations.
2.
Posterior restorations: Prepare the cavity. Line and point angles should be
rounded. No residual amalgam or other base material should be left in the
internal form of the preparation that would interfere with light transmission
and therefore, the hardening of the restorative material.
B. Pulp Protection: If a pulp exposure has occurred and if the situation warrants a
direct pulp capping procedure, use a minimum amount of calcium hydroxide on
the exposure followed by an application of 3M™ Vitrebond™ Light Cure Glass
Ionomer Liner/Base. Vitrebond liner/base may also be used to line areas of deep
cavity excavation. See Vitrebond liner/base instructions for details.
C. Placement of Matrix:
1.
Anterior restorations: Mylar strips and crown forms may be used to minimize the amount of material used.
2.
Posterior restorations: Place a thin dead-soft metal, or a precontoured-mylar
or a precontoured-metal matrix band and insert wedges firmly. Burnish the
matrix band to establish proximal contour and contact area. Adapt the band
to seal the gingival area to avoid overhangs
Note: The matrix may be placed following the enamel etching and adhesive
application steps if preferred.
D. Adhesive System: Follow the manufacturer’s instructions regarding etching,
priming, adhesive application and curing.
E. Dispensing the Composite: Follow the directions corresponding to the dispensing system chosen.
1.
Syringe:
a)
Dispense the necessary amount of restorative material from the syringe
onto the mix pad by turning the handle slowly in a clockwise manner.
To prevent oozing of the restorative when dispensing is completed, turn
the handle counterclockwise a half turn to stop paste flow. Immediately
replace syringe cap. If not used immediately, the dispensed material
should be protected from light.
b) Place restorative into the cavity using a nonmetallic placement instrument.
2.
Single-Dose Capsule: Insert capsule into 3M™ Restorative Dispenser. Refer
to separate restorative dispenser instructions for full instructions and precautions. Extrude restorative directly into cavity.
F. Placement:
1.
Place and light cure restorative in increments as indicated in Section G.
2.
Slightly overfill the cavity to permit extension of composite beyond cavity
margins. Contour and shape with appropriate composite instruments.
31
3.
Avoid intense light in the working field.
4.
Posterior placement hints:
a) To aid in adaptation, the first 1mm layer may be placed and adapted to
the proximal box.
b) A condensing instrument (or similar device) can be used to adapt the
material to all of the internal cavity aspects.
G. Curing: 3M™ Filtek ™ Z250 restorative will cure only by exposure to light. Cure
each increment by exposing its entire surface to a high intensity visible light
source, such as a 3M curing light. Hold the light guide tip as close to the restorative as possible during light exposure. The recommended exposure time and
maximum increment thickness for each shade is shown below.
Shade
A1, A2, A3, A3.5, A4,
B1, B2, B3
C2, C3
D3,
I
B0.5, C4, UD
Thickness
Exposure Time
2.5mm
20 seconds
2.0mm
30 seconds
H. Finishing: Contour restoration surfaces with fine finishing diamonds, burs or
stones. Contour proximal surfaces with 3M™ Sof-Lex ™ Finishing Strips.
I.
J.
Adjust Occlusion: Check occlusion with a thin articulating paper. Examine
centric and lateral excursion contacts. Carefully adjust occlusion by removing
material with a fine polishing diamond or stone.
Polishing: Polish with 3M Sof-Lex Finishing and Polishing System and with
white stones or rubber points where discs are not suitable.
III. Indirect Procedure For Inlays, Onlays Or Veneers
A. Dental Operatory Procedure
1.
2.
Shade selection: Choose the appropriate shade(s) of Filtek Z250 restorative
prior to isolation. If the restoration is of sufficient depth, use of an opaque
shade is recommended. Use of an Incisal shade on the occlusal surface will
help to achieve esthetic appearance.
Preparation: Prepare the tooth.
3.
Impressioning: After preparation is complete, make an impression of the
prepared tooth by following the manufacturer’s instructions of the
impressioning material chosen. A 3M impressioning material may be used.
B. Laboratory Procedure
1. Pour the impression of the preparation with die stone. Place pins at the
preparation site at this time if a “triple tray” type of impression was used.
2.
3.
4.
5.
6.
Separate the cast from the impression after 45 to 60 minutes. Place pins in
die and base the cast as for a typical crown and bridge procedure. Mount or
articulate the cast to its counter model to an adequate articulator.
If a second impression was not sent, pour a second cast using the same
impression registration. This is to be used as a working cast.
Section out the preparation with a laboratory saw and trim away excess or,
expose the margins so they can be easily worked. Mark the margins with a
red pencil if needed. Add a spacer at this time if one is being used.
Soak the die in water, then with a brush, apply a very thin coat of separating
medium to the preparation, let it dry somewhat, then add another thin layer.
Add the first third of composite to the floor of the preparation, stay short of
the margins, light cure for 20 seconds.
7.
32
8.
Add second third of composite. Allow for the last third (incisal) to include
the contact areas, light cure for 20 seconds.
Place the die back into the articulated arch add the last third of incisal composite to the occlusal surface. Overfill very slightly mesially, distally, and
occlusally. This will allow for the mesiodistal contacts and the proper occlusal contact when the opposing arch is brought into occlusion with the
uncured incisal increment. Light cure for only ten seconds, then remove the
die to prevent adhering to adjacent surfaces. Finish the curing process.
9.
With the occlusal contacts already established, begin removing the excess
composite from around the points of contact. Develop the inclines and
ridges as per remaining occlusal anatomy.
10. Care must be taken when removing the prosthesis from the die. Break off
small amounts of the die from around the restoration, the die stone should
break away cleanly from the cured restoration, until all of the restoration is
recovered.
11. Using the master die, check the restoration for flash, undercuts, and fit.
Adjust as necessary, then polish.
C. Dental Operatory Procedure
1. Roughen the interior surfaces of the indirect restoration.
2.
3.
Clean the prosthesis in a soap solution in an ultrasonic bath and rinse thoroughly.
Cementation: Cement the prosthesis using a 3M resin cement system by
following manufacturer’s instructions.
IV. Storage and Use:
A. Do not expose restorative materials to elevated temperatures or intense light.
B. Unopened kits should be refrigerated (40oF or 4 oC) to extend shelf life. Allow to
come to room temperature for use
C. Do not store materials in proximity to eugenol containing products.
D. The composite pastes are designed for use at room temperature of approximately
21- 24 oC or 70 - 75 oF. Shelf life at room temperature is 3 years.
V. Warranty
3M will replace product that is proven to be defective. 3M does not accept liability for
any loss or damage, direct or consequential, arising out of the use or the inability to
use these products. Before using, the user shall determine the suitability of the product
for its intended use and user assumes all risk and liability whatsoever in connection therewith.
Trademarks Cited
Primsa TPH ™, TPH™ Spectrum, Caulk® and Dentsply ® are trademarks of Dentsply International. Herculite
XRV™, Prodigy ™ are trademarks of Kerr Corporation. Tetric® and Tetric Ceram ™, Direct Ceromer™ are
trademarks of Ivoclar Vivadent. Charisma®, Microglass ® are trademarks of Heraeus Kulzer, Inc. Vita™ is a
trademark of Vita Zahnfabrik, Bad Sackingen Germany. 3M™, Filtek ™, Scotchbond ™, P-50 ™, Z100 ™, Sof-Lex ™
and Vitrebond ™ are trademarks of 3M.
Dental Products Laboratory
3M Center, Building 260-2B-13
St. Paul, MN 55144-1000
Printed in U. S. A.
©1998 3M
70-2009-2054-7